GHIATAS

Additional Manufacturer Narrative

AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 02/2025).

Description of Event or Problem

IT WAS REPORTED THAT DURING A MAMMOGRAPHY GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE GHIATAS BEADED BREAST LOCALIZATION INTRODUCER NEEDLE AND LOCALIZATION WIRE WERE RETURNED FOR EVALUATION. ON VISUAL EVALUATION, THE DEVICE APPEARED CLEAN AND THE LOCALIZATION WIRE AND CANNULA WERE RETURNED SEPARATED. AND IT WAS NOTED THAT THERE WERE BENDS THROUGHOUT THE BRAIDED LOCALIZATION WIRE. DUE TO THE CONDITION OF THE DEVICE FUNCTIONAL TESTING WAS NOT PERFORMED. ALTHOUGH THE LOCALIZATION WIRE AND CANNULA WERE RETURNED SEPARATELY AND THERE WAS BEND NOTED TO THE LOCALIZATION, EXACT CONDITION OF USE CANT BE REPLICATED. THEREFORE, THE INVESTIGATION FOR THE REPORTED DIFFICULT TO REMOVE IS KEPT AS INCONCLUSIVE AS THERE WERE NO FUNCTIONAL TESTING PERFORMED. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED DIFFICULT TO REMOVE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT DURING A MAMMOGRAPHY GUIDED BREAST BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.